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Trial record 40 of 597 for:    Fluzone® | Studies With Results

A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years

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ClinicalTrials.gov Identifier: NCT02212106
Recruitment Status : Completed
First Posted : August 8, 2014
Results First Posted : October 16, 2015
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Seqirus

Brief Summary:
This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) Biological: Comparator Quadrivalent Influenza Virus Vaccine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase IV, Multicenter, Randomized, Observer-blind, Parallel-arm Study to Evaluate the Safety and Tolerability of CSL's Trivalent Influenza Virus Vaccine (CSL TIV) in Children 5 to Less Than 9 Years of Age.
Study Start Date : September 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
Biological: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.

Active Comparator: Comparator Quadrivalent Influenza Virus Vaccine
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Biological: Comparator Quadrivalent Influenza Virus Vaccine
Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
Other Name: Fluzone Quadrivalent




Primary Outcome Measures :
  1. The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine. [ Time Frame: 7 days after each administration of vaccine. ]
    The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)


Secondary Outcome Measures :
  1. The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine. [ Time Frame: 7 days after each administration of vaccine. ]
    The overall percentage of subjects reporting at least one fever event after administration of the comparator influenza virus vaccine. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C).

  2. The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine. [ Time Frame: 7 days after each administration of vaccine. ]
    Percentage of subjects with a related fever event (overall) by study vaccine group based on the number of subjects contributing any follow up safety information for at least one data value of an individual sign/symptom. Excludes subjects with missing intensity information for the whole 7 days. Mild fever: ≥ 100.4 to < 101.3º F (≥ 38.0 to < 38.5º C). Moderate fever: ≥ 101.3 to < 102.2º F (≥ 38.5 to < 39.0º C). Severe fever: ≥ 102.2º F (≥ 39.0º C).

  3. The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine. [ Time Frame: 7 days after each administration of vaccine. ]
    The overall frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of bioCSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.

  4. The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine. [ Time Frame: 7 days after each administration of vaccine. ]
    The overall frequency and intensity of solicited systemic Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.

  5. The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine. [ Time Frame: 7 days after each administration of vaccine. ]
    The overall frequency and intensity of unsolicited Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall.

  6. The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine. [ Time Frame: 7 days after each administration of vaccine. ]
    The number of subjects experiencing at least one SAE.



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Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males or females aged 5 to less than 9 years at the time of first study vaccination.
  • The subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements.
  • In good health, as determined by medical history and a targeted physical examination (if warranted).

Exclusion Criteria:

  • Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines.
  • Clinical signs of significant active infection or an elevated oral temperature at study entry.
  • A clinically significant medical or psychiatric condition.
  • A history of seizures or febrile convulsions or Guillain-Barré syndrome.
  • Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
  • Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation.
  • Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry.
  • Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine.
  • Currently receiving treatment with warfarin or other anticoagulants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212106


Locations
United States, California
Site 286
Los Angeles, California, United States, 90036
United States, Idaho
Site 289
Boise, Idaho, United States, 83642
United States, Missouri
Site 287
Saint Louis, Missouri, United States, 63141
United States, New York
Site 285
Binghamton, New York, United States, 13901
United States, North Carolina
Site 290
Durham, North Carolina, United States, 27704
Site 281
Raleigh, North Carolina, United States, 27609
Site 280
Winston-Salem, North Carolina, United States, 27103
United States, South Carolina
Site 284
Charleston, South Carolina, United States, 29403
United States, Texas
Site 283
Austin, Texas, United States, 78705
Site 282
Fort Worth, Texas, United States, 76135
Site 288
San Angelo, Texas, United States, 76904
Sponsors and Collaborators
Seqirus
Investigators
Study Director: bioCSL Pty Ltd Clinical Program Director Seqirus

Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT02212106     History of Changes
Other Study ID Numbers: CSLCT-USF-10-69
2015-000175-27 ( EudraCT Number )
First Posted: August 8, 2014    Key Record Dates
Results First Posted: October 16, 2015
Last Update Posted: October 16, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs